Concerta

Concerta Manufacturers

• Physicians Total Care, Inc.
  

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  Concerta | Physicians Total Care, Inc.

  

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  2.1 General Dosing Information

  CONCERTA® should be administered orally once daily in the morning with or without food.

  CONCERTA® must be swallowed whole with the aid of liquids, and must not be chewed, divided, or crushed [see Patient Counseling Information (17)].

  2.2 Patients New to Methylphenidate

  The recommended starting dose of CONCERTA® for patients who are not currently taking methylphenidate or stimulants other than methylphenidate is 18 mg once daily for children and adolescents and 18 or 36 mg once daily for adults (see Table 1).

  TABLE 1. CONCERTA® Recommended Starting Doses and Dose Ranges Patient Age Recommended Starting Dose Dose Range Children 6–12 years of age 18 mg/day 18 mg – 54 mg/day Adolescents 13–17 years of age 18 mg/day 18 mg – 72 mg/day
  not to exceed 2 mg/kg/day Adults 18–65 years of age 18 or 36 mg/day 18 mg – 72 mg/day 2.3 Patients Currently Using Methylphenidate

  The recommended dose of CONCERTA® for patients who are currently taking methylphenidate twice daily or three times daily at doses of 10 to 60 mg/day is provided in Table 2. Dosing recommendations are based on current dose regimen and clinical judgment. Conversion dosage should not exceed 72 mg daily.

  TABLE 2. Recommended Dose Conversion from Methylphenidate Regimens to CONCERTA® Previous Methylphenidate Daily Dose Recommended CONCERTA® Starting Dose 5 mg Methylphenidate twice daily or three times daily 18 mg every morning 10 mg Methylphenidate twice daily or three times daily 36 mg every morning 15 mg Methylphenidate twice daily or three times daily 54 mg every morning 20 mg Methylphenidate twice daily or three times daily 72 mg every morning

  Other methylphenidate regimens: Clinical judgment should be used when selecting the starting dose.

  2.4 Dose Titration

  Doses may be increased in 18-mg increments at weekly intervals for patients who have not achieved an optimal response at a lower dose. Daily dosages above 54 mg in children and 72 mg in adolescents have not been studied and are not recommended. Daily dosages above 72 mg in adults are not recommended.

  A 27-mg dosage strength is available for physicians who wish to prescribe between the 18-mg and 36-mg dosages.

  2.5 Maintenance/Extended Treatment

  There is no body of evidence available from controlled trials to indicate how long the patient with ADHD should be treated with CONCERTA®. It is generally agreed, however, that pharmacological treatment of ADHD may be needed for extended periods.

  The effectiveness of CONCERTA® for long-term use, i.e., for more than 7 weeks, has not been systematically evaluated in controlled trials. The physician who elects to use CONCERTA® for extended periods in patients with ADHD should periodically re-evaluate the long-term usefulness of the drug for the individual patient with trials off medication to assess the patient's functioning without pharmacotherapy. Improvement may be sustained when the drug is either temporarily or permanently discontinued.

  2.6 Dose Reduction and Discontinuation

  If paradoxical aggravation of symptoms or other adverse events occur, the dosage should be reduced, or, if necessary, the drug should be discontinued.

  If improvement is not observed after appropriate dosage adjustment over a one-month period, the drug should be discontinued.

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• Janssen Pharmaceuticals, Inc.
  

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  Concerta | Pd-rx Pharmaceuticals, Inc.

  

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  Valacyclovir tablets may be given without regard to meals. Valacyclovir oral suspension (25 mg/mL or 50 mg/mL) may be prepared extemporaneously from 500 mg valacyclovir tablets for use in pediatric patients for whom a solid dosage form is not appropriate [see Dosage and Administration (2.3)]. 2.1 Adult Dosing Recommendations

  Cold Sores (Herpes Labialis): The recommended dosage of valacyclovir hydrochloride for treatment of cold sores is 2 grams twice daily for 1 day taken 12 hours apart. Therapy should be initiated at the earliest symptom of a cold sore (e.g., tingling, itching, or burning).

  Genital Herpes: Initial Episode: The recommended dosage of valacyclovir hydrochloride for treatment of initial genital herpes is 1 gram twice daily for 10 days. Therapy was most effective when administered within 48 hours of the onset of signs and symptoms.

  Recurrent Episodes: The recommended dosage of valacyclovir hydrochloride for treatment of recurrent genital herpes is 500 mg twice daily for 3 days. Initiate treatment at the first sign or symptom of an episode.

  Suppressive Therapy: The recommended dosage of valacyclovir hydrochloride for chronic suppressive therapy of recurrent genital herpes is 1 gram once daily in patients with normal immune function. In patients with a history of 9 or fewer recurrences per year, an alternative dose is 500 mg once daily.

  In HIV-infected patients with a CD4+ cell count greater than or equal to 100 cells/mm3, the recommended dosage of valacyclovir hydrochloride for chronic suppressive therapy of recurrent genital herpes is 500 mg twice daily.

  Reduction of Transmission: The recommended dosage of valacyclovir hydrochloride for reduction of transmission of genital herpes in patients with a history of 9 or fewer recurrences per year is 500 mg once daily for the source partner.

  Herpes Zoster: The recommended dosage of valacyclovir hydrochloride for treatment of herpes zoster is 1 gram 3 times daily for 7 days. Therapy should be initiated at the earliest sign or symptom of herpes zoster and is most effective when started within 48 hours of the onset of rash.

  2.2 Pediatric Dosing Recommendations

  Cold Sores (Herpes Labialis): The recommended dosage of valacyclovir hydrochloride for the treatment of cold sores in pediatric patients greater than or equal to 12 years of age is 2 grams twice daily for 1 day taken 12 hours apart. Therapy should be initiated at the earliest symptom of a cold sore (e.g., tingling, itching, or burning).

  Chickenpox: The recommended dosage of valacyclovir hydrochloride for treatment of chickenpox in immunocompetent pediatric patients 2 to less than18 years of age is 20 mg/kg administered 3 times daily for 5 days. The total dose should not exceed 1 gram 3 times daily. Therapy should be initiated at the earliest sign or symptom [see Use in Specific Populations (8.4), Clinical Pharmacology (12.3), Clinical Studies (14.4)].

  2.3 Extemporaneous Preparation of Oral Suspension

  Ingredients and Preparation per USP-NF: Valacyclovir tablets 500 mg, cherry flavor, and Suspension Structured Vehicle USP-NF (SSV). Valacyclovir oral suspension (25 mg/mL or 50 mg/mL) should be prepared in lots of 100 mL.

  Prepare Suspension at Time of Dispensing as Follows:

  Prepare SSV according to the USP-NF. Using a pestle and mortar, grind the required number of valacyclovir 500 mg tablets, until a fine powder is produced (5 valacyclovir tablets for 25 mg/mL suspension; 10 valacyclovir tablets for 50 mg/mL suspension). Gradually add approximately 5 mL aliquots of SSV to the mortar and triturate the powder until a paste has been produced. Ensure that the powder has been adequately wetted. Continue to add approximately 5 mL aliquots of SSV to the mortar, mixing thoroughly between additions, until a concentrated suspension is produced, to a minimum total quantity of 20 mL SSV and a maximum total quantity of 40 mL SSV for both the 25 mg/mL and 50 mg/mL suspensions. Transfer the mixture to a suitable 100 mL measuring flask. Transfer the cherry flavor* to the mortar and dissolve in approximately 5 mL of SSV. Once dissolved, add to the measuring flask. Rinse the mortar at least 3 times with approximately 5 mL aliquots of SSV, transferring the rinsing to the measuring flask between additions. Make the suspension to volume (100 mL) with SSV and shake thoroughly to mix. Transfer the suspension to an amber glass medicine bottle with a child-resistant closure. The prepared suspension should be labeled with the following information “Shake well before using. Store suspension between 2° to 8°C (36° to 46°F) in a refrigerator. Discard after 28 days.”

  *The amount of cherry flavor added is as instructed by the suppliers of the cherry flavor.

  ​2.4 Patients with Renal Impairment

  Dosage recommendations for adult patients with reduced renal function are provided in Table 1 [see Use in Specific Populations (8.5, 8.6), Clinical Pharmacology (12.3)]. Data are not available for the use of valacyclovir hydrochloride in pediatric patients with a creatinine clearance less than 50 mL/min/1.73 m2.

  Table 1. Valacyclovir Hydrochloride Dosage Recommendations for Adults With Renal Impairment  Normal Dosage  Creatinine Clearance (mL/min)  Regimen  (Creatinine  Clearance   Indications  ≥50 mL/min)  30-49  10-29  <10 Cold sores (Herpes labialis)  Two 2 gram  Two 1 gram  Two 500 mg  500 mg single  doses taken  doses taken  doses taken  dose Do not exceed 1 day of treatment.  12 hours apart  12 hours apart  12 hours apart Genital herpes:  1 gram every  no reduction  1 gram every  500 mg every Initial episode  12 hours  24 hours  24 hours Genital herpes:  500 mg every  no reduction  500 mg every  500 mg every Recurrent episode  12 hours  24 hours  24 hours Genital herpes: Suppressive therapy   Immunocompetent patients  1 gram every  no reduction  500 mg every  500 mg every  24 hours  24 hours  24 hours   Alternate dose for  500 mg every  no reduction  500 mg every  500 mg every   immunocompetent  24 hours  48 hours  48 hours   patients with   ≤9 recurrences/year   HIV-infected patients  500 mg every  no reduction  500 mg every  500 mg every  12 hours  24 hours  24 hours Herpes zoster  1 gram every  1 gram every  1 gram every  500 mg every  8 hours  12 hours  24 hours  24 hours

  Hemodialysis: Patients requiring hemodialysis should receive the recommended dose of valacyclovir hydrochloride after hemodialysis. During hemodialysis, the half-life of acyclovir after administration of valacyclovir hydrochloride is approximately 4 hours. About one third of acyclovir in the body is removed by dialysis during a 4-hour hemodialysis session.

  Peritoneal Dialysis: There is no information specific to administration of valacyclovir hydrochloride in patients receiving peritoneal dialysis. The effect of chronic ambulatory peritoneal dialysis (CAPD) and continuous arteriovenous hemofiltration/dialysis (CAVHD) on acyclovir pharmacokinetics has been studied. The removal of acyclovir after CAPD and CAVHD is less pronounced than with hemodialysis, and the pharmacokinetic parameters closely resemble those observed in patients with end-stage renal disease (ESRD) not receiving hemodialysis. Therefore, supplemental doses of valacyclovir hydrochloride should not be required following CAPD or CAVHD.

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